De-Epithelialization Techniques for Gum Recession

Overseen By Sandra Stuhr, DMD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Anticoagulants, Antiplatelets, Antibiotics, Immunosuppressants

Disqualifiers: Diabetes, Autoimmune, Pregnancy, Hematologic, Cancer, others

Compensation: Varies

Number of Visits: 5

Duration: 1 day

48 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare different de-epithelialization methods in patients undergoing soft tissue augmentation surgery. The main questions it aims to answer are: • Which technique is superior for de-epithelialization in terms of remaining epithelium, wound healing of the donor site, and clinical outcomes?

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people on anticoagulant or antiplatelet therapy and those on certain drug therapies for systemic conditions. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment for gum recession?

The study on the healing response of gingival recessions treated with expanded polytetrafluoroethylene membranes showed a significant reduction in recession depth and an increase in tissue coverage, suggesting that similar surgical techniques can effectively improve gum conditions. ^{1 2 3 4 5}

Is de-epithelialization using Er:YAG laser safe for treating gum recession?

Research shows that using the Er:YAG laser for de-epithelialization in gum recession treatment is generally safe, with no significant differences in clinical outcomes compared to traditional methods, and patients reported better esthetic results. ^{1 2 4 6 7}

How does the de-epithelialization treatment for gum recession differ from other treatments?

This treatment is unique because it uses an Er:YAG laser for de-epithelialization, which can provide a more uniform and aesthetically pleasing appearance of the gums compared to traditional methods like scalpels. The laser technique is non-contact and uses a sweeping motion, which may enhance patient comfort and satisfaction with the esthetic outcomes. ^{1 6 8 9 10}

Research Team

Sandra Stuhr, DMD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with good physical and mental health who need dental surgery involving soft tissue grafts. They must be able to follow study instructions but can't join if they have infections, recent heavy antibiotic use, uncontrolled diabetes, are pregnant or nursing, have severe blood disorders, cancer treatments within the last 18 months, smoke heavily, or have liver/kidney diseases.

Inclusion Criteria

I am in good or mild systemic disease state according to ASA.

I am having a gum surgery that includes taking tissue samples without needing extra anesthesia.

I am physically and mentally fit for routine dental care.

Exclusion Criteria

I have an autoimmune or inflammatory condition like lupus or rheumatoid arthritis.

Pregnant women or nursing mothers, or unsure of pregnancy status (self-reported)

I have a severe blood disorder like leukemia or hemophilia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo soft tissue augmentation surgery using one of four de-epithelialization techniques: mucotome, Er:YAG laser, surgical diamond bur, or blade

1 day

1 visit (in-person)

Follow-up

Participants are monitored for wound healing and patient-reported outcomes on post-operative days 1, 7, 14, and 21

3 weeks

4 visits (in-person)

Treatment Details

Interventions

• Diamond Bur
• Er:YAG Laser
• Mucotome
• Surgical Blade

Trial Overview The trial compares four techniques of gum preparation in dental surgery: using a surgical blade, mucotome device, diamond bur tool or an Er:YAG laser. It looks at how much gum remains after treatment and how well the wound heals.

Participant Groups

Group I: Mucotome Experimental Treatment 1 Intervention

A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Group II: Er:YAG Laser Experimental Treatment 1 Intervention

A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Group III: Diamond Bur Experimental Treatment 1 Intervention

A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Group IV: Surgical Blade Placebo Group 1 Intervention

A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Delta Dental Foundation

Collaborator

Trials

8

Recruited

1,400+

References

1. United States pubmed.ncbi.nlm.nih.gov

Pedicle flaps, gingival grafts, and connective tissue grafts in aesthetic treatment of gingival recession. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Prevalence and severity of vestibular recession in mandibular incisors after orthodontic treatment. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Coronally advanced flap procedure for root coverage. Treatment of root surface: root planning versus polishing. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Healing response of human buccal gingival recessions treated with expanded polytetrafluoroethylene membranes. A retrospective report. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Gingival abrasion and recession in manual and oscillating-rotating power brush users. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Effects of Er:YAG Laser for the De-Epithelialization of the Palatal Graft in the Treatment of Multiple Gingival Recessions: A Randomized Clinical Trial. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of laser adjunctive therapy for surgical treatment of gingival recession with flap graft techniques: a systematic review and meta-analysis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Use of the carbon dioxide laser in retarding epithelial migration: a pilot histological human study utilizing case reports. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Laser de-epithelialization for enhanced guided tissue regeneration. A paradigm shift? [2007]

10. United States pubmed.ncbi.nlm.nih.gov

The effect of working tip angulation on root substance removal using Er:YAG laser radiation: an in vitro study. [2019]